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United States · US · US:72189-134_2c4ea3ff-7a39-c7f4-e063-6294a90a5746

BUPROPION HYDROCHLORIDE

Orange BookUNIISPLATC N06AX12

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerDIRECT RX
CountryUS (United States)
ATC codeN06AX12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7218913430
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-134-30)
  • ndc11
    7218913460
    60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-134-60)
  • ndc11
    7218913472
    120 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-134-72)
  • ndc11
    7218913490
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-134-90)

Annotations

UNII (FDA Substance ID)
ZG7E5POY8O
BUPROPION HYDROCHLORIDE
RxCUI 203204
Orange Book
A210497
AB3AB3
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "ZG7E5POY8O",
    "rxcui": "203204",
    "inchikey": "HEYVINCGKDONRU-UHFFFAOYSA-N",
    "display_name": "BUPROPION HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "cefaaa17-f79a-4ba6-8f97-a59f60e07b75": {
      "match": "brand_token",
      "title": "BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
      "spl_version": "105",
      "published_date": "2026-06-01"
    }
  },
  "productid": "72189-134_2c4ea3ff-7a39-c7f4-e063-6294a90a5746",
  "productndc": "72189-134",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "210497",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Oct 31, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Oct 31, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPROPION HYDROCHLORIDE",
  "proprietary_name": "BUPROPION HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210497",
  "marketing_category": "ANDA",
  "nonproprietary_name": "BUPROPION HYDROCHLORIDE",
  "start_marketing_date": "20201015",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code N06AX12.

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